China Finalizes the Regulations for Cosmetic Adverse Reaction Monitoring
On February 21, 2022, China National Medical Products Administration (NMPA) released the finalized Measures for the Management of Cosmetic Adverse Reaction Monitoring (the Measures), which will take effect on Oct. 1, 2022.
The Measures is China’s first regulation specifically for the management of cosmetic adverse reaction monitoring. It consists of 7 Chapters and 47 Articles, stipulating systematic requirements for cosmetic adverse reaction monitoring. The highlights of the Measures include:
Establishing the national cosmetic adverse reaction monitoring management system, and clarifying the responsibilities and obligations of each subject in adverse reaction monitoring;
Standardizing the requirements for each link of cosmetic adverse reaction monitoring;
Specifying that the adverse reactions caused by cosmetics added with new ingredients will be subject to the investigations by provincial medical products administration departments. Risk control measures will be taken if the products are found to have safety risks. Specific regulations will be formulated separately. [ChemLinked News]
China NMPA Consults on the Key Points for Reviewing of Cosmetic Safety Assessment Report
Starting from February 21, 2022, a draft of Key Points for Reviewing of General Cosmetics Safety Assessment Report (Simplified Version) (the Key Points) proposed by China NMPA has been under discussion among cosmetic industry insiders. National Institutes for Food and Drug Control, provincial MPAs, and inspection centers are required to provide feedback before March 31, 2022.
The Key Points clarifies the requirements for data collation and technical review of the safety assessment report, stipulates the judgment principles for reviewing the safety assessment report, etc. [ChemLinked News]
China NMPA Approves Two New Cosmetic Ingredients
In February 2022, China NMPA updated the notification information of two new cosmetic ingredients (NCIs). The basic information of the new NCIs is as follows:
|INCI Name||β- nicotinamide Mononucleotide||Polymethylsilsesquioxane / Trimethylsiloxysilicate|
|Purpose of Use||Antioxidant||unpublished|
|The Maximum Concentration||unpublished||unpublished|
|Notifier||Yuyao Lifespan Health Technology Co., Ltd.||Grant Industries, Inc|
China to Further Expand the CBEC Comprehensive Pilot Zone
On January 22, 2022, the State Council issued an official reply which approved establishing 27 new cross-border e-commerce (CBEC) comprehensive pilot zones. The provincial governments are responsible for rolling out the detailed plans. [Reference Link]
Before the issuance of the reply, the State Council had approved establishing 105 CBEC comprehensive pilot zones, covering 30 provinces, autonomous regions and municipalities. With the latest expansion, there will be a total of 132 CBEC comprehensive pilot zones in China. [Reference Link]
China Updates CBEC Positive List
On February 21, 2022, eight departments (including Ministry of Finance, National Development and Reform Commission, Ministry of Industry and Information Technology, Ministry of Ecological Environment, Ministry of Agriculture and Rural Affairs, Ministry of Commerce, General Administration of Customs, and Endangered Species Import and Export Management Office of PRC) jointly announced to optimize the List of Import Goods through Cross-border E-commerce.
Compared with the current 2019 version, the optimization lies in the following aspects:
Adding 29 items into the positive list;
Adjusting the tariff code based on the recent adjustment of tariff rules;
Adjusting the remarks of 206 items;
Removing 1 item from the positive list.
The new list has come effect on March 1, 2022. [ChemLinked News]
China Proposes Ten Group Standards in February
China proposed ten group standards in February. The basic information is as follows:
|Release Date||Initiator||Group Standard||Source|
|February 8, 2022||China Association of Fragrance Flavor and Cosmetic Industries||Group Standard of Liquidambar oil||Reference Link|
|Group Standard of Schisandra oil|
|February 14, 2022||Guangdong Cosmetics Association||Test Method of Antioxidant Effect in Cosmetics||Reference Link|
|Evaluation Method of Antioxidant Effect in Zebrafish Embryos|
|Group Standard of Cosmetic Ingredient: Bifida Ferment Lysate|
|Test Method of Facial Cosmetics for Sensitive Skin|
|Hair-refresh Dry Shampoo|
|Shampoo and Body Wash Mousse for Children|
|Group Standard of Cosmetic Ingredient: Prinsepia Utilis Oil|
Beijing Municipal MPA Releases Administrative Measures on Cosmetics Production License
On February 21, 2022, Beijing Municipal MPA released an announcement to implement the Administrative Measures on Cosmetics Production License in Beijing (the Measures). The Measures stipulates the basic application requirements, acceptance conditions, supervision and inspections, etc., for enterprises that intend to engage in cosmetics production in Beijing to refer to when they apply, renew or cancel the production licenses. It has come into effect on March 1, 2022. [Reference Link]
China General Administration of Customs (GACC): 3 Batches of Cosmetics Rejected in January
On February 16, 2022, GACC updated the list of rejected food and cosmetics in January. Three batches of cosmetics respectively imported from France, United States and Australia failed customs inspection. The reasons for rejections were the excessive use of arsenic and unqualified labels. [Reference Link]
Taiwan Releases Two Test Methods for Cosmetics
On February 11, 2022, Taiwan Food and Drug Administration released two test methods for cosmetics. The basic information is as follows:
The European Union
EU to Amend Cosmetic Ingredient Use Requirements: 14 Newly Prohibited Ingredients and 2 Newly Restricted Ingredients
On February 1, 2022, the EU released an amendment to the Regulation (EC) No 1223/2009, in which Methyl-N-methylanthranilate (M-N-MA) (CAS No 85-91-6) was newly included into the restricted ingredients list with use restriction. The amendment has come effect since February 21, 2022.
Later on February 3, 2022, EU issued a new draft of Commission Regulation to amend the Annexes to Regulation (EC) No 1223/2009. The draft is open for comments until April 4, 2022, whose detailed amendments include:
Adding 14 prohibited ingredients
Deleting 1 prohibited ingredient
Adding 1 restricted ingredient
Amending 1 permitted preservative
EU to Ban the Use of 5 Batches of Nanomaterials in Cosmetics
On February 11, 2022, the EU updated a new draft of Commission Regulation to enforce the prohibition on nanomaterials in cosmetic products. The new draft proposed to include 5 batches of nanomaterials into the prohibited ingredients list in the Regulation (EC) No 1223/2009. It is currently open for comments until April 12, 2022. [ChemLinked News]
South Korea Intensifies Safety Managements on Custom Cosmetics
As the enhanced requirements of custom cosmetics in Cosmetics Act came into effect on February 18, 2022, the amendments on facility standards, material reporting, and other administrative provisions in its downstream laws are updated on the same day.
The amendments include:
Detailing new penalty standards in Enforcements Decree of Cosmetics Act;
Specifying custom cosmetic facility standards and material reporting methods in Enforcement Rule of Cosmetics Act;
Updating Provisions in the administrative regulations following the upstream acts.
South Korea Designates New Packaging Materials as Difficult-to-Recycle Level
On February 28, 2022, the Ministry of Environment (MOE) modified the Packing Material Recyclability Rating Standard to adjust the recyclability level of "composite material containers and trays" and "composite material film and sheet". Manufacturers and importers of these materials need to re-conduct an assessment material recyclability levely, and then submit the results to KEC before September 30, 2022.
PMDA: 82 Batches of Cosmetics Imported from France Were Recalled in February
On February 1, 2022, Japan Pharmaceuticals and Medical Devices Agency (PMDA) announced that 82 batches of non-compliant cosmetics were recalled. According to the announcement, the statutory label was not attached to the container but to the outer box, which was the reason of recall. [Reference link]
Thailand FDA Requires Warnings on Tampon Labels
Following the reclassification of tampons as cosmetic products on June 29, 2021, Thailand Food and Drug Administration (Thailand FDA) announced the requirements for the warnings on tampon labels on January 21, 2022. Specifically, the following warning information shall be displayed on tampon labels:
Never use the tampon when the container is broken.
Never wear the same tampon for more than 8 hours. Please change each tampon every 4 to 8 hours.
Remove the tampon and seek medical attention immediately if symptoms such as sudden fever, vomiting, diarrhea, fainting, or dizziness occur, or if rashes appear on the skin.
The announcement took effect on January 22, 2022. Cosmetic stakeholders who have manufactured, imported, or sold tampons before that date shall comply with the new requirements within 180 days after the entry into force. [Reference Link]
In the US, the Food and Drug Administration (FDA) does not require pre-approval of cosmetic products and ingredients (with the exception of color additives) prior to being placed on the market. This is often misunderstood to mean that cosmetics aren't regulated in the US. Although the FDA doesn't require pre-approval of cosmetics, there are very specific requirements prohibiting the adulteration or misbranding of cosmetics, which ensures the products being offered for sale do not pose risk of harm to users under normal conditions of use. ChemLinked will host webinars on March 10 (English Session) and March 15 (Korean Session) to overview the US regulatory framework for cosmetics. Welcome to register here.